Looking at the safety of primaquine when given by mouth once a week for 8 weeks to Cambodian patients with vivax malaria.
Assessing the safety of weekly administered primaquine in vivax malaria infected Cambodians.
National Center for Parasitology, Entomology & Malaria Control
150 participants
Jan 12, 2013
Interventional
Conditions
Summary
Primaquine is a drug that is used to kill malaria parasites that sleep in the liver. Plasmodium vivax and plasmodium ovale are the scientific names of the malaria species that can sleep in the liver. The species These sleeping forms of malaria can wake up and enter the blood where they will cause another bout of malaria. Primaquine is not widely used because it can cause red cells on the blood to break open if they are short of an enzyme called glucose 6 phosphate dehydrogenase, G6PD for short. With little or no G6PD, the red cell cannot produce certain substances to protect itself when it is under stress from certain drugs like primaquine and also fava beans. G6PD deficiency is common in many parts of the world, especially where there is malaria. There are tests that can be used to see if someone is G6PD deficient but many countries do not use them because of cost and the logistical challenges involved. As a result primaquine is not used because of the risk of causing harm to patinets due to the red cells breaking apart is too high. Our research project will look closely at the risk of effects of red cells breaking apart by giving G6PD deficient patients and seeing what happens. We will monitor the patients very closely and have developed a good safety net to detect any health problems quickly. The results of this research will provide useful information for the Ministries of Health that are trying to control malaria.
Eligibility
Inclusion Criteria6
- Male or non pregnant females aged > 1 year
- Weight >= 10 kg
- Presentation with: (i) acute (within 10 days), symptomatic (i.e. history of fever), uncomplicated, Plasmodium vivax mono- or mixed infection, AND (ii) vivax asexual parasitaemia = 200 & < 200,000 parasites/microL
- Written informed consent provided by the volunteer. Witnessed consent is permitted, if the individual cannot write.
- Able and willing to participate based on information given to the volunteer
- Not currently taking any prescribed, over the counter or herbal drugs that could cause haemolysis in G6PD deficiency
Exclusion Criteria8
- Hb < 8 g/dL for a patients of all ages
- Have any malaria danger signs: unable to swallow because of vomiting, >=2 convulsions within previous 24 hours, reduced level of consciousness, unable to sit or walk unaided.
- Any clinically significant disease requiring treatment or further investigation
- Pregnant, planning to become pregnant
- Breast feeding
- For a G6PD deficient child under 5 – living more than 25 km from the research site
- Allergic to primaquine or DHA-PP known to have had a clinically significant, contraindicating adverse reaction to either drug
- Having taken part in research involving an investigational drug within the past 8 weeks.
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Interventions
Oral primaquine at a dose of 0.75 mg/kg given once per week for 8 weeks AND Oral dihydroartemisinin piperaquine given once per day for 3 days according to the maufacturer's dosing instructions. This regimen will be given to patients with vivax malaria and G6PD deficiency.
Locations(1)
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ACTRN12613000003774